Quattro®

FDA UDI

Class II (US FDA UDI)

by Cayenne Medical, Inc.

Identity

Trade Name: Quattro® FDA UDI
Generic Name: Polyolefin/fluoropolymer suture, multifilament FDA UDI
Model / Reference: CM-9500 FDA UDI

Identifiers

Catalog Number: CM-9500 FDA UDI
Primary DI / UDI-DI: M543CM9500 FDA UDI
FDA Product Code: GAR FDA UDI
GAW FDA UDI
GAT FDA UDI
GAB FDA UDI
GMDN Term: Polyolefin/fluoropolymer suture, multifilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5020 FDA UDI
878.5010 FDA UDI
878.5000 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Polyolefin/fluoropolymer suture, multifilament Suturing needle, single-use

Quattro® by Cayenne Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cayenne Medical, Inc.

Sources (1)

FDA UDI ca0962e7-19c6-4f9a-9636-582b959128fb 33 fields · synced May 29, 2026